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To evaluate the safety and tolerability of the Chiron vaccine human immunodeficiency virus (HIV) p24(25 or 50 micrograms)/MF59 in healthy HIV-1 seronegative adults. To evaluate the immunogenicity of the HIV p24(50 micrograms)/MF59 vaccine.
Full description
This study evaluates the safety and immunogenicity of the Chiron vaccine HIV p24/MF59. In Part A, 15 volunteers are randomly assigned to receive either HIV p24/MF59 or a placebo at 0, 1, and 6 months. 10 volunteers receive the vaccine and 5 volunteers receive the placebo. If no serious adverse events are observed within 1 week after the first injection in these first 15 patients, Part B is initiated. In Part B, 25 volunteers are randomly assigned to receive HIV p24/MF59 or a placebo at 0, 1, and 6 months. 20 volunteers receive the vaccine and 5 volunteers receive the placebo.
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Volunteers
Inclusion and exclusion criteria
Inclusion Criteria
Volunteers must have:
Exclusion Criteria
Co-existing Condition:
Volunteers with the following symptoms or conditions are excluded:
Volunteers with the following prior conditions are excluded:
History of immunodeficiency, autoimmune disease, or any serious chronic illness.
Evidence of psychiatric or medical history or substance abuse that would adversely affect the volunteer's ability to participate in the trial.
History of anaphylaxis or other serious adverse reactions to vaccines or vaccine components.
Live, attenuated vaccine within 60 days of study entry.
NOTE:
Engaging in high-risk behavior within 6 months of study entry, i.e.:
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Data sourced from clinicaltrials.gov
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